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The U.K. Medicines and Healthcare Products Regulatory Agency, concerned about potential shortages when new rules requiring regulator certificates go into effect July 2, has said that it will allow API imports lacking such written confirmation on a case-by-case basis to ensure continued supplies. Imports should still have a valid EU good manufacturing practices certificate, and drug firms will need to have audited the API manufacturing site within the past three years.

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A senior Ugandan health official alleged that strict enforcement of international patent protections would prevent thousands from gaining access to live-saving drugs for such diseases as malaria, tuberculosis and HIV/AIDS. Government medical adviser Denis Kibira charged that global pharmaceutical firms want to roll back intellectual-property provisions that allow for production of cheaper generic medicines to deal with public health crises.

India will set the maximum price for the remainder of the 348 drugs on its National List of Essential Medicines by the end of the month, according to C.P. Singh, chairman of the National Pharmaceutical Pricing Authority. The prices for more than 200 drugs on the list were set previously. Industry representatives contend that the new controls could cut prices for cancer drugs and antibiotics by as much as 80%, although Singh noted that, so far, reductions have been in the 15% to 20% range.

An online article in the British Medical Journal calls for making unpublished and misreported clinical trials public so that the findings can be corrected in medical journals if the clinical trial sponsors will not do so themselves. The idea of "restorative authorship" has also been endorsed by PLOS Medicine. "The public interest requires that we have a complete view of previously conducted trials and a mechanism to correct the record for inaccurately or unreported trials," the authors said.

Nine drug firms have been given fines by the EU, including Denmark's Lundbeck, Germany's Merck and India's Ranbaxy, totaling $195 million for payments to delay the release of lower-priced generic versions of brand-name drugs, or "pay for delay" schemes. "Agreements of this type directly harm patients and national health systems, which are already under tight budgetary constraints," said EU Competition Commissioner Joaquin Almunia. Lundbeck and Ranbaxy have said they will appeal.

New EU import regulations of about 300 active pharmaceutical ingredients could result in shortages in Britain because of an estimated 300 sites that, lacking valid certifications, will require onsite inspections. Yet Britain's Medicines and Healthcare products Regulatory Agency says it lacks the resources to conduct inspections on such a scale. "Based on the latest analysis, inspection of those sites in third countries that are not planning to issue statements or apply for lisitng cannot be seen as a solution," the MHRA stated.